The position will report directly to the Deputy General Counsel/Chief Compliance Officer and be a key member of s’ legal team. The position’s primary responsibility will be to (a) provide strategic and legal advice in relation to the commercialization of the Company’s investigational and approved branded pharmaceutical products and (b) support the Company’s compliance function through training, investigations, and overall regulatory support. The position will provide legal support to a wide range of internal clients, including human resources, marketing, market access, sales, medical, regulatory and healthcare compliance. The candidate is expected to have a firm background in healthcare law pertaining to commercial, regulatory and healthcare compliance issues. The ideal candidate will also have experience advising on product pricing, managed care access and reimbursement, and government pricing requirements. This person should exhibit superior legal skills combined with critical thinking and problem solving to serve as a strategic business partner by providing clear legal advice and practical business-focused solutions enabling the business to achieve its objectives while preserving and protecting the Company’s integrity and reputation.
This position requires an ability to understand and evaluate competing perspectives and provide clear guidance. The position would be expected to
• Advise clients on a broad array of issues relating to the advertising and promotion of prescription pharmaceutical drug products including, but not limited to, Food Drug and Cosmetic Act and its implementing regulations, OPDP guidance, Anti-kickback Statute, False Claims Act, OIG Guidance, PhRMA Code and Sunshine Act
• Counsel and support the Company’s compliance function to ensure that the Company’s healthcare compliance programs reflect applicable laws, rules, regulations and guidance and perform internal investigations with regard to same.
• Serve as the legal representative on the Company’s Medical Legal Review Committee (MLR), which also includes colleagues from medical affairs and regulatory
• Provide advice to commercial, medical and corporate teams on programs, engagements, grants, sponsorships, as well as other activities and initiatives to ensure compliance with relevant healthcare laws, guidance documents, advisory opinions, enforcement, and settlements (FDA, OIG, DOJ)
• Provide advice on pricing, reimbursement, channel marketing, patient support, financial assistance, and other market access matters, including government pricing and state price transparency reporting
• Provide Legal advice and support regarding policies and procedures to ensure compliance with federal and state healthcare laws and regulations governing drug promotion, field customer engagement and incentive compensation, financial arrangements with healthcare providers (e.g., gifts, grants, consulting, etc.), transparency reporting (e.g., Sunshine Act), scientific communications (e.g., symposiums, CME, publications), access and reimbursement, government pricing, channel marketing, and interactions with foreign entities
• Provide Legal advice with respect to various commercial agreements, including marketing activities (vendor, consultant), managed care access (MCO, PBM, GPO), channel distribution (wholesale, specialty pharmacy), and patient support (HUB)
• Keep informed of new laws, regulations, and industry trends affecting the company
• Counsel on commercial launch preparation activities
• Advise on brand-related strategic planning, operating plans and budgeting matters.
• Train Company personnel, including sales personnel
As part of a relatively small, but growing, legal department, the candidate may be required to assist on various projects outside of the primary scope of responsibility
Experience and Skills
• Juris Doctor (JD) and admission to the Jersey state bar (or eligibility for licensure as a registered in-house counsel in New Jersey)
• Minimum 3 years of relevant healthcare, pharmaceutical or biotech experience.
• Experience as in-house counsel preferred
• In-depth knowledge of commercial, compliance and regulatory matters associated with the launch and subsequent commercialization of branded pharmaceutical products
Required Knowledge and Abilities
• Ability to multitask and manage workload effectively, setting priorities and delivering results on agreed timelines
• Exceptional interpersonal, written and verbal communications skills, including the ability to communicate complex issues and concepts to non-attorneys
• Superior attention to detail with emphasis on follow-through and quality results
• Ability to work both independently and as a member of a team in a results-oriented environment
• Strong problem-solving and decision-making skills with demonstrated ability to think creatively and devise solutions to challenging problems
• Ability to manage and influence across a cross-functional matrix organization
• Team player with the desire to be helpful in the context of a relatively small but rapidly growing organization
Assistant General Manager